This application claims the priority of international application number PCT/CH99/00416, filed Sep. 7, 1999, which in turn claims the priority of German patent application number 198 40 965.6, filed Sep. 8, 1998, both of which are incorporated herein by reference.
The invention relates to a module for a computer interface, the module being used to monitor the state of health of a person. More particularly, the present invention provides an apparatus for and a method of health monitoring and control wherein a module for a computer interface including a transducer wherein the transducer receives a measurement value and makes this measurement value available for monitoring an individual""s health by means of the computer interface, for example, for monitoring an individual""s blood glucose level, wherein the measurement value is obtained by means of a sensor.
Monitoring the state of health of persons has become increasingly important. This particularly applies to the execution of therapies requiring a dosed administration of one or more active substances depending on the state of health of the person concerned. Such a therapy may be, for example, diabetes therapy, where insulin is administered in synchronization with the glucose concentration measured or detected by measurement in and/or of a body fluid of the person.
The monitoring methods in the context of therapies require special devices just for the purpose of making measurement data available either to care-givers such as doctors, nurses, etc. or to the person to be treated. Such monitoring devices are complex and expensive or only allow monitoring activities to a very restricted extent. In diabetes therapy, where the glucose concentration in a body fluid, particularly the blood-sugar content, is decisive, the known devices for monitoring the glucose concentration just indicate the currently measured concentration. Evaluating and monitoring features are at least very limited. A user who administers himself with insulin, or with the corresponding active substance in another therapy, would be able to adapt this administration to his personal requirements more precisely if, for example, xe2x80x9chistoricalxe2x80x9d data were also available to him. He could coordinate his physical activities, eating habits and the doses of active substances to be administered more precisely.
Accordingly, it is the object of the invention to enable a comfortable, inexpensive, and yet extensive, monitoring of the state of health of a person.
This object is solved by the invention in that a transducer, which receives or takes a measurement value and makes it available for monitoring the state of health of a person, has been designed as a module for an interface of a conventional computer. The measurement value is a value obtained by means of a sensor on or in the person to detect his/her state of health. The module can be integrated and connected to a defined interface of the computer. Accordingly, not only can it be supplied by computer manufacturers, but also by independent manufacturers at a later time.
In one embodiment, the module according to the invention is used to monitor the glucose concentration in a body fluid of the person, in particular to monitor the blood-sugar content.
An advantage of the present invention is that monitoring can be done by conventional computers that generally offer a higher performance, in particular with regard to the computing performance and display features, than so far possible with special devices used for monitoring purposes. Another advantage is that, especially in types of therapy requiring a person to administer himself with the corresponding active substance, this person can make use of a computer generally already available, which he already uses for other purposes and is already familiar with. It is also possible to transmit data concerning health from the module in accordance with the invention to other, widely used computer programs. The module in accordance with the invention or its computer software is compatible with the usual programs, such as, for instance, graphic, text and/or spread sheet programs. In one embodiment, the module in accordance with the invention is a plug-in module that may be advantageously inserted into a standard slot of a computer, such as, for example, in the form of the standard plug-in board or cards usual today for an external port of a computer. It can also be a plug-in module subsequently integrated into one of the slots available in the housing of a personal computer. In any case, the computer""s capacity is used. In particular, processor and monitor capacities, but also possibilities already available to connect peripheral devices can be exploited by the invention. Accordingly, to monitor his state of health, the user can make use of the computer surroundings he is already familiar with, which increases the readiness to accept such monitoring. Preferably, such a plug-in module is delivered together with the corresponding installation and application software required for monitoring, as is common with add-on plug-in modules.
The invention may be used with a computer of a device used for self-administration of a fluid product or with a computer used in combination therewith. The device comprises a fluid guiding means, a means for conveying a dose of fluid product to be administered, a wireless communication interface, a control for the conveying means, and a communications terminal. The fluid guiding means, conveying means and said interface are components of an administering device. The communications terminal is not physically connected to said device, i.e., these two devices are not mechanically connected to each other, at least when using the device. Any connection while stored or during transportation should, however, not be ruled out. The communications terminal is provided with another interface for wireless communication and with a visual display. Wireless communication occurs between the administration device and the communications terminal via these two interfaces. The administration device and the communications terminal remain with the user, who administers the fluid product to himself personally.
The fluid guiding means includes a reservoir for the fluid product and for the parts of the administration device connected therewith, and fluid passes through the guiding means during administration until a fluid outlet is reached. In the event that the administration device is fixed either to the body or to clothing, the fluid outlet is formed by a insertion needle.
In another embodiment, the conveying means, an emergency control therefor, an energy source and the wireless communication interface are implanted, and the reservoir is fixed either to the body or to the clothing, the fluid guiding means naturally also being partially implanted downstream of the reservoir; the conveying means, preferably a micro pump, is itself thus preferably part of said fluid guiding system. This is generally also possible for the other alternative embodiments with regard to the design of the administration device. Dividing the administration device into a body-external reservoir and a body-internal conveying means has the advantage that the external part can be diminished or the reservoir can be enlarged, and that the place of discharge of the fluid product can be selected particularly conveniently for therapy. At the same time, the health risks associated with an implanted reservoir are avoided.
The fluid product may be a liquid active solution as administered in the context or framework of a therapy, in particular insulin.
The wireless communication may be radio communication; however, ultrasonic or infrared communication is also conceivable.
The communications terminal monitor displays at least one operating parameter of the administration device. Thus, a person administering himself with the fluid product can monitor the operation of the administration device, and thus the administration, directly and comfortably by means of the communications terminal. The user does not have to detach the administration device to read the display, as he can read the data of interest to him on the display of the communications terminal which is already detached, irrespective of the place where the administration device has been attached. Accordingly, the administration device can be fixed at any suitable place, e.g., to the user""s clothing or directly to the user""s body for an administration cycle until the reservoir is filled again. Thus, carrying the device becomes much more comfortable for the user. The administration device can be constantly positioned under clothing, for example under a pull-over, so that it is invisible to other persons, which renders the device much more acceptable. The facilitated readability simultaneously increases safety, amongst other things, since the user checks the display more often. Further display means can be provided at the administration device, but are no longer required, and are preferably not, or only to a reduced extent, available at the device.
One operating parameter of the administration device which is of interest to the user is the amount of fluid administered. In the course of a continuous or almost continuous product distribution, the amount of fluid is preferably displayed as feed rate over time. In particular, the fluid amounts supplied in discrete time intervals are displayed, the time intervals either being given or selectable with regard to the therapy and, if desired, also with regard to the individual user requirements.
The amount of fluid administered during a given time interval is preferably determined from the position of the conveying means. Comparing a position at the end of a time interval to a known starting position at the beginning of said time interval calculates the amount of fluid supplied during the respective time interval, i.e., by subtraction and scaling the fluid reservoir. Storing the positions passed or the supplied amounts detected during administration allows or translates to representing the amount of fluid administered over the time. Such a representation is preferably a graphic representation. To increase the safety of administration, any deviation from a given desired position may also be represented, for example also over the time of administration. In case the deviation from a given desired position is too large, it would be advantageous to display a warning signal to signalize to the user that there is a considerable deviation, or even to indicate the extent of deviation and, expediently, also the moment when such a deviation occurred. Furthermore, it can also be beneficial to display the course of time of such deviation between the desired amount of supply and the amount of fluid actually supplied. The position of the conveying means preferably also allows to determine the residual amount of fluid product still available, since each position is directly assigned a given residual amount when the fluid reservoir does not change in form and size, i.e. if, for example, ampoules of same size are always used or if changes are recognized automatically or manually entered at the communications terminal.
The position of the conveying means can be a desired position given by a control for controlling the conveying means precisely to said position. According to another embodiment, the actual position of the conveying means obtained by a sensor is used to determine the amount supplied and the further operating parameters that can be derived therefrom.
In a one embodiment, the fluid guiding means is monitored with regard to an occlusion. The communications terminal indicates the occurrence of an occlusion and preferably the extent thereof. An occlusion can either cause total interruption of the supply or a supply at reduced supply rate. In case of total interruption, the conveying means is automatically stopped and the total interruption is indicated by an alarm signal at the communications terminal. If the supply is continued despite an occlusion, the actual supply rate is just smaller than a given supply rate, and if this interruption in operation is due to an occlusion in the fluid conveying system, this may be indicated on the communications terminal visual display, especially by means of a graphical warning symbol and, simultaneously, by a suitable representation of the deviation occurred. In the event of a deviation due to a conveying error caused by the conveying means, the user can directly compensate the conveying error at the next opportunity to do so. A total occlusion may be stored as an event in a memory of the communications terminal together with the time of detection. In the event of a reduced supply, the extent of which can be determined due to the position of the conveying means, it is stored over its course of time. As already stated above, it is possible to represent either the amounts of supply or the supply rate in absolute form, or the deviation from the desired supply.
In another embodiment, a leakage in the fluid guiding system may be detected and sent to the communications terminal, where it is indicated by an alarm signal. The leakage information may be stored as an event in a memory of the communications terminal together with the time of detection so that it is available for later evaluation of the course of administration.
The occurrence of an occlusion may be detected by means of a sensor that measures a reaction force the conveying means exerts on a support of said conveying means. The measured reaction force is constantly compared to a suitably given threshold value, which when exceeded indicates an occlusion. The same sensor may also be used to detect a leakage. The measured reaction force is then additionally compared to a suitably given threshold value. If the measured force of reaction remains under such a threshold value, this indicates a leakage.
A means to produce a defined pressure drop is preferably provided in a flow cross section of the fluid guiding system. The pressure drop is of such large dimension that the force required for the conveying means to overcome this flow resistance is considerably larger than the other forces determining the reaction force occurring if the administration device works properly. Accordingly, an occlusion, and in particular a leakage, can be detected with particular reliability.
A communications terminal, which may be, at the same time, a remote indicator and remote control, offers the most conceivable convenience as concerns portability. Owing to the remote control, a user cannot only monitor, but also use, his administration device discretely, should this be required, e.g., in a restaurant or at any other social event. Data can be entered into the communications terminal by means of keys, a touch screen or a voice-entry means with integrated microphone, the latter may also be provided in addition to a manually operable input means to enable data to be entered in all situations with utmost convenience and discretion.
The physical size used to determine the at least one operating parameter, preferably the position of the conveying means and/or the reaction force exerted by said conveying means, is entered into a processor of the device to generate the operating parameter therefrom. If said processor is a component of the administration device, the operating parameter generated by said processor is entered into the interface of said administration device and then further transmitted to the interface of the communications terminal. Preferably, such a processor is a component of the communications terminal, and the physical size is transmitted.
A control for the conveying means, which can be influenced or operated by the user, can be a component of the administration device. The user can change the setting of such a control by means of an input means of the communications terminal, e.g., to administer an extra dose.
In one embodiment, a control that can be influenced, in particular a programmable control or the entire variable part of the control of the conveying means, is a component of the communications terminal. Provided in the administration device is a part of the control, which can only be provided directly at the conveying means, if need be a wireless controlled power component of said conveying means, e.g., in the form of just one pulsed interrupter of the energy supply of said conveying means.
If the communications terminal comprises the variable control part, the administration device may include a an emergency control used to further run a fixed administration program automatically and self-sufficiently in the event of the wireless communication failing until it is switched off. The emergency control can be provided in addition to the wireless triggered minimum control part of the main control. It can, however, also be formed by the wireless-controlled control means in the course of normal operation that switches to emergency operation if no control signals are obtained within a given period of time. The emergency control can operate in accordance with a standard program, which is the same for all administration devices of the same series, or is also adjusted individually, preferably by means of programming which, according to the setting of the user, is carried out in a wireless manner via the interface of the administration device by means of the communications terminal or any other suitable device, which is conventionally done by a doctor. In some embodiments, it does not include further adjusting features, but rather runs the standard or individual program once set.
The administration device can easily be designed waterproof, since a housing has few openings, e.g., for input means. In extreme cases, only the interface region and the outlet for the fluid guiding means must be sealed.
According to one embodiment, an evaluation means for monitoring the state of health of a person, in particular of the user of the device, can be combined with the communications terminal or is a fixedly integrated component thereof. The evaluation means may be a component of the module according to the invention.
An obtained measurement value is evaluated by the evaluation means by determining a corresponding body value therefrom. An evaluation result may be indicated on another monitor or preferably the monitor of the communications terminal, already mentioned. If the device according to the invention is used for insulin treatment, it may be an evaluation means used to determine the blood-sugar content; it can also be used to additionally determine the hormone level and/or a relevant body temperature. Generally, however, such an evaluation means is not restricted to determine blood-sugar measurement values or the measurement values and groups of measurement values previously mentioned. If used for other therapies, where not insulin but other active substances are being administered, other measurement values adapted to the corresponding application would be obtained and evaluated.
The measurement value can be transmitted wirelessly as a measuring signal by a sensor. The evaluation means comprises a transducer to receive said signal. In this embodiment, the transducer is either formed by the interface of the communications terminal or as an additional receiving part. In another embodiment, a sensor, which is or was in contact with the sample, is inserted into the transducer in its contact area, which thereby obtains the measuring signal of the sensor by direct contact. In both cases, the transducer is the link between the sensor and the communications terminal or another platform for the evaluation means.
In the embodiment including the sensor, which has to be introduced physically, the sensor and the evaluation means may correspond to sensors and evaluation means known from insulin therapy. However, in contrast thereto, the evaluation means according to the invention is compatible with the communications terminal or a common computer, which is, however, adapted to the application.
According to the invention, the transducer is an integrated component of the module, in particular a standard plug-in board or card for computers, e.g. a PCMCIA board or card, and can thus be connected to usual well-known types of computers such as personal computers, notebooks and pocket-sized computers by simply being plugged into a computer slot provided for this purpose. The plug-in board or card may be thought of as a transducer, i.e., as a transmitting means for the measurement values of the sensor. The subsequent processing of the measurement values until the body values are obtained can be performed by components comprised in the home computer. In this embodiment, the plug-in board or card may be thought of as a sensor port. In another embodiment, means used to process the measurement values is also an integrated part of the board or card. The board or card may include a non-volatile memory to temporarily store the measurement values or the measurement values already processed. The plug-in board or card can be delivered with a preinstalled or installable special application software.
The plug-in board or card may include an integrated sample taking set comprising a number of sensor elements and means to take samples. Alternatively, such a sample taking set can also be a component of the communications terminal, in particular if the evaluation means is an integrated component of the communications terminal.
In one embodiment, the communications terminal is a standard computer in pocket format, e.g., a hand-held or preferably a palm-sized computer. The interface of the communications terminal for wireless communication with the administration device is formed by a plug-in board or card, e.g., a PCMCIA board or card, for a computer slot. The same plug-in board or card may include the transducer that may be designed with additional components on the board or card up to an evaluation means, thus simultaneously forming the communication interface and sensor port.
The integration of an evaluation means or also only a transducer in one module, preferably in a plug-in module, in particular a plug-in board or card, may advantageously also be applied in combination with administration devices that do not have a detached communications terminal. Such a modular solution can advantageously be used for any therapy monitoring in order employ larger calculating and storing capacities, in comparison to known devices, and also more extensive display possibilities of a computer. As a plug-in module, this solution may be a product that can be sold independently.
Configuration, diagnosis or quality control, and programming or pre-setting of the administration device may be done by the manufacturer in a wireless manner by means of a computer. In particular, the wireless communication facilitates execution of quality checks. As this does not require any wire connections, configuration and diagnosis may be performed without interrupting production if an interface for wireless communication is suitably provided.
Additional features and advantages of the present invention will be provided by references to the accompanying drawings, the following description and the appended claims.